Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

NCT01239836 | Completed

• 1 other identifier: CIHR-200909-CUK-202417
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. The aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. The main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.

Conditions

Urinary Incontinence

Keywords

urinary incontinence, self-management, cost, self-efficacy, continence promotion

Outcome Measures

Primary Outcomes (1)

• Incontinence frequency

  Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.

  3 months

Secondary Outcomes (2)

• Cost of pad use

  3 months

• Self-efficacy for managing incontinence

  3-months

Study Arms (4)

Self-management

EXPERIMENTAL

Behavioral: Evidence-based self-management tool

General Health Lecture

SHAM COMPARATOR

Behavioral: General health lecture

Combined workshop and self-management

EXPERIMENTAL

Behavioral: Constructivist interactive workshop on urinary incontinence; Behavioral: Evidence-based self-management tool

Workshop

EXPERIMENTAL

Behavioral: Constructivist interactive workshop on urinary incontinence

Interventions

Constructivist interactive workshop on urinary incontinence BEHAVIORAL

A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.

Combined workshop and self-management; Workshop

Evidence-based self-management tool BEHAVIORAL

Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.

Combined workshop and self-management; Self-management

General health lecture BEHAVIORAL

Participants will attend a lecture on general women's health issues that does not address urinary incontinence.

General Health Lecture

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years or older
• Urinary incontinence twice weekly
• Women who have not sought medical advice for incontinence symptoms in the last 2 years.
• Fluent in English

You may not qualify if:

• Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence).
• Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment.
• Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation.
• Women who do not consent to participate.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead
• Brunel University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Brunel University

Uxbridge, Middlesex, UB8 3PH, United Kingdom

Location

Related Publications (2)

• Tannenbaum C, Drali R, Holroyd-Leduc J, Richard L. Lessons learned: impact of a continence promotion activity for older community-dwelling women. Neurourol Urodyn. 2010 Apr;29(4):540-4. doi: 10.1002/nau.20800.

  PMID: 19693950 BACKGROUND

• Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.

  PMID: 24334159 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara Tannenbaum, MD

  Centre de recherche de l'Institut universitaire de gériatrie de Montréal

  PRINCIPAL INVESTIGATOR

• Eleanor van den Heuvel, PhD

  Brunel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

GB (1)